Out of Specification

OOS – Out of Specification

Raw Material Testing sometimes results in an out of specification. This forms an OOS that must be investigated and reported as per the guidance from Regulatory Authorities. Considering the manufacturing priorities and the amount of time required for Re-Testing and Re-Sampling, weaken the investigation process, leaving scope for unidentified root cause and repeated OOS which will result in major product failure. With time factor being crucial and to overcome un-negotiable priorities, an automated Out of Specification Management Software is a required tool to accelerate investigations and conclude thoroughly.

The Out of Specification is used by drug manufacturers to ensure that drug products are produced within the desired specifications. Whenever the drug or product is not meeting the required standards then it can be specified as results of Out of Specification. As per the FDA OSS guidelines is important that quality issues are to be effectively resolved after phase wise investigation, RCA (Root Cause Analysis), CAPA or Change Control

AmpleLogic OOS Management Software offers electronic record management with an ability to retrieve and store all relevant documents as per your need. Out of Specification Software ensure compliance with FDA 21 CFR Part 11 Requirements, EU Annex 11, GMP and cGMP Practices, etc.     

OOS Record Management Software Solution

Out of Specification Management System automates the process of handling with raw materials or finished products from initial reporting to batch release or rejection through phase wise investigations and with any associated CAPA before closure. This enables the organization to reduce their OOS reporting time, evaluate for its repetition with ease of access to its records/ reports and disintegrate investigation into multiple tasks such as Re-Sampling, Re-Analysis tasks, Review tasks that can be assigned, completed or tracked. During Post investigation, initiate any associated corrective action/ preventive actions and implement with effectiveness checks at an integrated CAPA Management System. Therefore it will improve OOS closure timelines with overdue controls as well as auto escalations.

With flexible and configurable workflows, it is easy for the OOS Management Solution to be transitioned into your current OOS handling process within a short period of time. This Comprehensive Tracking and Trending will automatically generate Summary Reports and Metrics Reports with a click of a button. This Summary Report gives real-time information within the selected OOS and metrics reports will give you in-depth performance visibility of a Quality System across the organization at any given point.

Besides providing the best approach for effective closure of OOS and Management Software is in full compliance with electronic records and management regulations such as 21 CFR Part 11, by providing complete audit trails, e-signatures, controlled access, and printing, records management and archival in accordance to regulatory standards and policies of an organization.

Benefits of AmpleLogic Out of Specification Management

AmpleLogic Out of Specification Management Software Solution has been developed based on extensive research on OOS guidelines from various regulatory agencies, and to be practical and problem-oriented with these core benefits:

  • Enterprise-wide 24 x 7 accessibility
  • Ensure to meet compliance with pharmaceutical and Biotech Industry regulations i.e. 21 CFR Part 11, EU Annexure 11 and GMP (Goods Manufacturing Practice), etc.
  • Improved Closure timelines with best-practiced workflows
  • Reduces the risk of product non – conformance and helps in reducing customer/market complaints and as well as deviations
  • Live tracking and traceability of OOS with status, automated alerts or notifications.
  • Fast-track investigations prevent delays in customer shipment and ensure product quality/ safety.
  • Helps to create any custom reports according to OOS templates as per your need
  • Easily integrates and establish closed-looping with other Quality Systems such as CAPA (Corrective and Preventive Action)
  • Harmonization and Accuracy in initial data capture through business Logics applied to fields such as rounding off results to two decimals.
  • Auto triggering of second phase investigation based upon the conclusion of the first

AmpleLogic Out of Specification Management Solution has several key features that enable the organization and as well as users to continuously improve the way OOS is handled

Key Features of Out of Specification Management

Simplified OOS Reporting

The reporting involves a lot of description and data capturing. By aligning the fields in an easy to define a pattern, initiators can describe an OOS and provide all related information without much manual data entry. Automated routing to pre-defined individuals such as lab supervisors ensures that the time involved in figuring out who to notify and how to respond is drastically reduced resulting in an optimized and simplified OOS reporting.

Phase wise Investigation

The reported OOS is investigated in the first phase through re-analysis tasks assigned to an initiator and concluded for the assignable cause. A non-assignable cause will automatically trigger in second phase investigation across cross-functional departments. Further, the investigation is concluded through a series of tasks such as document review, re-testing and re-sampling tasks that can be created, assigned, tracked for completion across different departments. This brings investigators across one platform and provides organized coordination without the need for individual one-to-one meetings or discussions.

Integrated Quality Systems

The Out of Specification Management System is designed to be flexible in integrating with other quality systems and establish a seamless, controlled workflow between OOS Management System and with rest of quality systems specially CAPA Management. The CAPAs originating can be initiated and closed at CAPA Management with enabled status tracking at OOS Management.

Automated Alerts & Notifications

This is a practical feature that ensures the users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue to the concerned authority and helps to resolve the issue.

Industries that can benefit from our Out of Specification Solution
  • Pharmaceuticals
  • Biotechnology
  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages